14/11/2022 - Lantheus Holdings Inc.: Material Agreement - Form 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 11, 2022

LANTHEUS HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Delaware		001-36569		35-2318913
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

331 Treble Cove Road

North Billerica, Massachusetts01862

(Address of principal executive offices) (Zip code)

Registrant's telephone number, including area code: (978)671-8001

Not Applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common stock, par value $0.01 per share		LNTH		The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 1.01

Entry Into a Material Definitive Agreement

On November 11, 2022, Lantheus Two, LLC ("Lantheus Two"), an indirect wholly owned subsidiary of Lantheus Holdings, Inc. (the "Company"), entered into a license and collaboration agreement (the "PNT-2002License Agreement") with an affiliate of POINT Biopharma Global Inc. ("POINT"), to co-developand commercialize PNT-2002,a prostate-specific membrane antigen-targeted radiopharmaceutical therapy for the treatment of metastatic castrate-resistant prostate cancer. Lantheus Medical Imaging, Inc. ("LMI"), a wholly owned subsidiary of the Company, will guarantee Lantheus Two's obligations under the PNT-2002License Agreement. Pursuant to the terms of the PNT-2002License Agreement, POINT has granted to Lantheus Two exclusive rights to develop and commercialize PNT-2002worldwide, except certain countries in Asia (the "Territory"). The parties' collaboration is governed through an executive steering committee and joint functional steering committees. The effectiveness of the transactions contemplated under the PNT-2002License Agreement are subject to specified conditions, including the expiration or early termination of any waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act").

POINT is generally responsible for funding and development activities required for U.S. Food and Drug Administration ("FDA") approval of PNT-2002,including generating all clinical and nonclinical data, analysis and other information, and Lantheus Two is responsible for preparing for and seeking regulatory approval for PNT-2002,as well as performing and funding all future development and commercialization of PNT-2002following such approval. POINT will be responsible for all manufacturing of PNT-2002,subject to certain exceptions described in the PNT-2002License Agreement.

Under the terms of the PNT-2002License Agreement, Lantheus Two will pay POINT an upfront cash payment of $250 million within five business days after the PNT-2002License Agreement becomes effective, with the potential for up to an additional $281 million in milestone payments upon the achievement of specified U.S. and ex-U.S.regulatory milestones related to PNT-2002.POINT is also eligible to receive up to $1.28 billion in sales milestone payments upon the achievement of specified annual sales thresholds of PNT-2002.In addition, after Lantheus Two achieves $500 million in cumulative Gross Profit, POINT is eligible to receive royalty payments of twenty percent of net sales of PNT-2002in the Territory. Prior to achieving that financial recoupment threshold, POINT is eligible to receive royalty payments of twenty percent on that portion of annual net sales of PNT-2002in the Territory that generate annual gross profit in excess of specified levels.

The PNT-2002License Agreement will remain in effect, unless terminated earlier, until the expiration of all royalty terms for PNT-2002in the Territory. The PNT-2002License Agreement may be terminated for cause by either party based on uncured material breach of the other party or bankruptcy of the other party. The PNT-2002License Agreement may be terminated prior to becoming effective upon the failure of certain closing conditions or upon notice from either party if the PNT-2002License Agreement has not been consummated on or prior to June 30, 2023, which date Lantheus Two may extend to August 30, 2023 upon payment of an extension fee. Lantheus Two may terminate the PNT-2002License Agreement without cause on specified notice periods, subject to the passage of time and specified milestones or triggers. Upon early termination by either party, all licenses granted by the parties will automatically terminate.

The description of the PNT-2002License Agreement in this Current Report on Form 8-Kdoes not purport to be complete and is qualified in its entirety by reference to the PNT-2002License Agreement, a copy of which is attached hereto as Exhibit 10.1 and incorporated by reference herein.

Item 8.01

Other Events

Also on November 11, 2022, Lantheus Three, LLC ("Lantheus Three" and, together with Lantheus Two, "Lantheus LLC"), an indirect wholly owned subsidiary of the Company, entered into a license and collaboration agreement (the "PNT-2003License Agreement" and, together with the PNT-2002License Agreement, the "License Agreements") with POINT to co-developand commercialize PNT-2003,a somatostatin receptor targeted radioligand ("SSTR") therapy with non-carrieradded lutetium-177,which is in development to treat patients with SSTR-positive neuroendocrine tumors. LMI will guarantee Lantheus Three's obligations under the PNT-2003License Agreement. Pursuant to the terms of the PNT-2003License Agreement, POINT has granted to Lantheus Three exclusive rights to develop and commercialize PNT-2003in the Territory. The parties' collaboration is governed through an executive steering committee and joint functional steering committees. The effectiveness of the transactions contemplated under the PNT-2003License Agreement are subject to specified conditions, including the expiration or early termination of any waiting period under the HSR Act.

POINT is responsible for curating all data, analysis and other information necessary for regulatory approval, and supporting Lantheus in the preparation of regulatory filings for PNT-2003,and Lantheus Three is responsible for preparing for and seeking regulatory approval of all such applications, as well as performing and funding all future development and commercialization of PNT-2003following such approval. POINT will be responsible for all manufacturing of PNT-2003,subject to certain exceptions described in the PNT-2003License Agreement.

Under the terms of the PNT-2003License Agreement, Lantheus Three will pay POINT an upfront cash payment of $10 million within five business days after the PNT-2003License Agreement becomes effective, with the potential for up to an additional $34.5 million in milestone payments upon the achievement of specified U.S. and ex-U.S.regulatory milestones related to PNT-2003.POINT is also eligible to receive up to $275 million in sales milestone payments upon the achievement of specified annual sales thresholds of PNT-2003.In addition, POINT is eligible to receive royalty payments of fifteen percent of net sales of PNT-2003in the Territory.

The PNT-2003License Agreement will remain in effect, unless terminated earlier, until the expiration of all royalty terms for PNT-2003in the Territory. The PNT-2003License Agreement may be terminated for cause by either party based on uncured material breach of the other party or bankruptcy of the other party. The PNT-2003License Agreement may be terminated prior to becoming effective upon the failure of certain closing conditions or upon notice from either party if the PNT-2003License Agreement has not been consummated on or prior to June 30, 2023, which date Lantheus Three may extend to August 30, 2023 at its option. At any time after filing the first application for obtaining market authorization for PNT-2003with the FDA, Lantheus Three may terminate the PNT-2003License Agreement without cause on 30 days' prior written notice. Upon early termination by either party, all licenses granted by the parties will automatically terminate.

The description of the PNT-2003License Agreement in this Current Report on Form 8-Kdoes not purport to be complete and is qualified in its entirety by reference to the PNT-2003License Agreement, a copy of which is attached hereto as Exhibit 10.2 and incorporated by reference herein.

Forward-Looking Statements

This Current Report on Form 8-Kand information included herein, contain forward-looking statements relating to, among other things, Lantheus LLC's partnership with POINT and the success thereof; POINT's and Lantheus LLC's abilities to successfully develop and commercialize PNT-2002and PNT-2003;and POINT's eligibility to receive development, regulatory and commercial milestone payments and royalties under the License Agreements. Any such statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential," "may," "will," "expects" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on the current expectations of the Company and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks that the FDA or other regulatory authorities may make adverse decisions regarding PNT-2002or PNT-2003;risks regarding closing conditions under the agreement with POINT, including review under the HSR Act; risks related to POINT's and Lantheus LLC's decisions regarding development, manufacture and commercialization of PNT-2002and PNT-2003;risks that PNT-2002and PNT-2003clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; the availability of resources to develop these product candidates; market competition; as well as other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission. The Company does not undertake any obligation to update any forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

Item 9.01

Financial Statements and Exhibits

(d) Exhibits

Exhibit Number		Exhibit Description
10.1*		License and Collaboration Agreement between Point Biopharma, Inc. and Lantheus Two, LLC, dated as of November 11, 2022
10.2*		License and Collaboration Agreement between Point Biopharma , Inc. and Lantheus Three, LLC, dated as of November 11, 2022
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

*	Certain confidential portions (indicated by brackets and asterisks) have been omitted from this exhibit.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: November 14, 2022